The plans about dietary supplements

The United States Food and Drug Administration (referred to as FDA) promulgated the "Dietary Supplement Health and Education Act" (DSHEA), which stipulates the following provisions for dietary supplements. A product (not tobacco) designed to supplement the diet may contain a One or more of the following dietary ingredients, a vitamin, a mineral, a herb (herbal) or other plant, an amino acid, a food ingredient used to increase the total daily intake to supplement the diet, or A concentrate, metabolite, ingredient, extract or combination product of the above ingredients. It also includes approved new drugs, vitamins or biological agents that have been marketed as dietary supplements or foods before approval, issuance, and approval. DSHEA defines dietary supplements as a definition of their composition content and labeling requirements: the product form can be pills, capsules, tablets or liquids; the product cannot replace ordinary food or be the only variety of the diet, and the product is identified as "dietary supplement"

Specific provisions

1. The product form can be pill, capsule, tablet or liquid.


2. It cannot replace ordinary food or be the only variety of diet.


3. Identified as "Dietary Supplements"


4. An approved new drug, a certified antibiotic, or a licensed biological agent, such as a product that has been marketed as a dietary supplement or food before it is approved, certified, or licensed.

Main plan

Announcement of the plan

On November 4, the FDA announced three major regulatory plans (initiatives) aimed at further implementing the Dietary Supplement Health and Education Act of 1994 (DSHEA). These plans—a regulatory strategy, an open public meeting, and a draft industry guidance document—are important steps the FDA has taken to implement DSHEA.

"These plans improve the FDA's approach to regulating dietary supplements," said Lester M. Crawford, Acting FDA Commissioner. "We now have a clear road sign shared with the dietary supplement industry, while at the same time giving consumers a higher level of assurance about the safety of dietary supplements and the reliability of their trademarks."

The purpose of the plan

The FDA plans to improve the transparency, predictability, and consistency of its scientific evaluation and regulatory actions, and oppose unsafe dietary supplements and make unapproved, false or misleading dietary supplements to protect consumers. The FDA will continue its ongoing efforts to monitor and evaluate product safety, ingredient safety and product labeling, and to ensure product quality. The FDA has issued a Federal Register notice regarding this public meeting, as well as two notices describing other plans.

The first plan

In the first plan, a regulatory strategy, the FDA will work with the federal and other partners to improve the evidence base used by the FDA to make decisions regarding the safety and enforcement of dietary ingredients and dietary supplements ( evidentiary base). Those partners include the National Institutes of Health Office of Dietary Supplements and the National Center for Complementary and Alternative Medicine, and the National Toxicology Program of the Department of Health and Human Services ( National Toxicology Program, the National Center for Natural Products Research of the University of Mississippi, the National Center for Toxicological Research of the FDA, and other institutions.

The FDA will also implement a transparent, systematic and predictable procedure to evaluate the safety of dietary ingredients and dietary supplements. The process begins with a "signal detection" (identifying a problem of concern). A possible signal of safety concern can come from: federal, state, and local counterparts, adverse event reports, foreign regulatory actions, media reports, information from consumer groups, and expert consultation. When the quality or quantity of these signals indicate that there may be a public health problem, the FDA will therefore seek signal input from an independent third party for review. FDA's regulatory actions will be based on all available scientific evidence, including the pharmacology of the substance, scientific literature, adverse event reports, and evidence-based review. The FDA has various options to implement its public health mission, including: making an unreasonable risk measurement, issuing public health advisories, educating consumers, conducting research, and requiring label changes.

According to DSHEA, dietary supplements do not require FDA approval before they are marketed. However, according to the law, for certain new dietary ingredients (NDI) (that is, dietary ingredients that were not marketed in the United States before October 15, 1994), A pre-market safety notice to the FDA is required.

The second plan

In order to promote the effective implementation of this requirement, the FDA has announced its second plan-a public meeting on November 15, 2004, which aims to discuss the type of evidence that manufacturers provide to FDA in a new dietary ingredient notification , Quantity and quality, solicit public opinions.

The FDA has not anticipated any immediate changes to its enforcement procedures. According to the FDA's clarification that a notice must be submitted to the substances that constitute a certain new dietary ingredient, the FDA will continue to communicate with the company. In addition, before implementing any next measures, FDA will fully review the opinions it has obtained from public meetings.

The FDA is committed to taking action against unsafe products. For example, a product that Fter determined to contain androstenedione, which can cause major health risks, and lacked NDI notifications, the FDA issued warning letters to 23 companies in March 2004, asking them to stop distribution as dietary supplements It sells products containing androstenedione and warns them that if appropriate measures are not taken, they may face further enforcement actions.

Another aspect of this strategy is to ensure product quality. The program addresses the need to establish industry-wide standards to help ensure that dietary supplements are consistently produced in terms of identity, purity, quality, concentration, and composition.

On March 13, 2003, the FDA issued a proposed rule regarding the current Good Manufacturing Practices (cGMP) requirements for dietary supplements. Currently, the FDA is reviewing and evaluating more than 1,600 pages of opinions. Issuing a final rule for cGMP is one of the FDA's highest priorities.

Since FDA is committed to protecting consumers and opposing dietary supplements that make false or misleading claims including unsubstantiated claims, FDA will also continue to monitor and evaluate dietary supplement labeling and take enforcement actions when appropriate. This measure will include surveillance label claims, including those in accompanying text materials such as flyers, brochures and catalogs, as well as claims in Internet labels.

Other measures include: identifying and taking enforcement actions against products whose labels fail to reveal material facts; targeting those products that pose the greatest risk to consumers; obtaining and analyzing dietary supplement samples in the market to verify their contents. The content is consistent with the label; and the Supplement Facts panels are reviewed to determine whether the substances listed as dietary ingredients in dietary supplements can be legally marketed.

About us

Alfa Chemistry is an analytical testing company that provides one-stop testing, analysis and technical support services in the areas of pharmaceutical analysis: pharmacological testing, environmental analysis, consumer product analysis: Beauty Products analysis, food analysis: edible oil testing, and material analysis: building products testing. As a professional testing and analysis organization, Alfa Chemistry has an experienced technical team that uses advanced analytical equipment and technology to meet the needs of different customers.